Commercial Manufacturing Quality Assurance Specialist
About The Position
Catalent’s Kansas City facility supports its Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services businesses. The Commercial Manufacturing Quality Assurance Specialist supports quality operations by reviewing batch records, ensuring compliance with FDA guidelines, and maintaining product quality standards. The role contributes to continuous improvement and works with cross-functional teams to uphold regulatory and internal standards in a science-driven environment. The position is Monday through Friday, 6 a.m. to 2 p.m., and is 100% onsite in Kansas City, Missouri.
Requirements
- Master’s degree in a scientific discipline with no experience; or a bachelor’s degree in a scientific discipline and at least 1 year of experience in Quality Assurance, Quality Control, or Regulatory Compliance in a Good Manufacturing Practice environment; or an associate degree and at least 3 years of experience in an FDA-regulated field plus at least 1 year in Quality Assurance, Quality Control, or Regulatory Compliance; or a high school diploma and at least 5 years of experience in an FDA-regulated field plus at least 1 year in Quality Assurance, Quality Control, or Regulatory Compliance.
Nice To Haves
- Six Sigma or American Society for Quality certification.
Responsibilities
- Perform batch record review, product release, and disposition.
- Draft, review, and approve technical documents, including procedures and master batch records.
- Ensure products are manufactured, tested, and released in accordance with applicable FDA guidelines, regulations, GXPs, and internal standard operating procedures.
- Participate in developing and maintaining quality assurance programs, procedures, and controls so products meet established standards and agency guidelines.
- Train, coach, and mentor others on technical, personal development, or business issues.
- Assist with data compilation for annual product review.
- Provide quality assurance advisement for project outcomes and customer interactions.
- Participate in developing and implementing process-related improvements.
- Assist with manufacturing-floor activities, including equipment and room approval and facility compliance.
- Perform other duties as assigned.
Benefits
- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team.
- Competitive paid time off and 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
